PERSONA® Vivacit-E® 42-5402-000-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00889024247697), received between Dec 5, 2019 and Jul 31, 2026 — classified as 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K121771, K172524); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a right knee arthroplasty revision to address patellar periprosthetic fracture and pain approximately two (2) years post-operatively.Attempts have been made and no further information has been provided.

  Patient problems: Pain; Periprosthetic fracture

  MAUDE report 50099667 ↗
• InjuryApr 27, 2026Malposition of Device

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL TKA. SUBSEQUENTLY, ABOUT 5 YEARS LATER, THE PATIENT HAD A REVISION WHICH PRIMARY GOAL WAS THE REPOSITION OF THE PATELLA WHICH WAS CAUSING PATELLOFEMORAL JOINT (PFJT) CONFLICT. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY OR FOREIGN BODIES RETAINED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Impingement

  MAUDE report 25001331 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3.5 YEARS POST-OP, THE PATIENT WAS EXPERIENCING PAIN WITHOUT RELIEF FROM PHYSIOTHERAPY, A PAIN MANAGEMENT SPECIALIST, AND REHABILITATION. IMAGING REVEALED INCREASED UPTAKE AT THE PATELLA AND MEDIAL TIBIAL AREA. SUBSEQUENTLY, THE PATIENT WAS REVISED. ALL COMPONENTS WERE REVISED. THERE WAS NO LOOSENING SEEN, HOWEVER, THE SURGEON NOTED AREAS OF SOFTER BONE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24052756 ↗
• InjuryDec 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 23770985 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND INSTABILITY APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. THE ARTICULAR SURFACE WAS UPSIZED AND THE PATELLA WAS REVISED AND RESURFACED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23450215 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POST-OP, THE PATIENT REPORTED EXPERIENCING LEFT KNEE PAIN, SWELLING, STIFFNESS, AND SOME FLUID ACCUMULATION. NO TREATMENT OR INTERVENTION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 22306623 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. APPROXIMATELY 7 DAYS POST IMPLANTATION, THE PATIENT PRESENTED TO THEIR PRIMARY CARE PROVIDER AND WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS. MEDICATION WAS GIVEN AS TREATMENT AND THIS WAS RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21055671 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cellulitis; Skin Discoloration; Swelling/ Edema; Unspecified Infection

  MAUDE report 21034997 ↗
• InjuryDec 11, 2024Malposition of Device; Malposition of Device

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 20901925 ↗
• InjuryNov 21, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY THREE (3) YEARS AND SEVEN (7) MONTHS POST-IMPLANTATION TO SWAP THE POLY BEARING BECAUSE OF A PATELLA CLUNK. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20750847 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY FOLLOWED BY A POST-OPERATIVE DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. SUBSEQUENTLY, AT THE TWO-YEAR FOLLOW-UP, THE PATIENT REPORTED INCREASING KNEE PAIN WITH TIGHTNESS AND SPASMS. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND INSTRUCTED TO MONITOR WATER AND ELECTROLYTE INTAKE. ALL IMPLANTS REMAIN IN PLACE AND IF THE SYMPTOMS PERSIST, WILL CONSIDER A FURTHER EVALUATION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Joint effusion; Pain; Swelling/ Edema

  MAUDE report 20517603 ↗
• MalfunctionOct 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407703 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY ONE YEAR POST-OP, THE PATIENT PRESENTED WITH PATELLAR PAIN WITH STRESSED LIGAMENTS. THE SURGEON THOUGHT HE DID NOT CUT ENOUGH BONE OFF WHEN HE INITIALLY RESURFACED THE PATELLA DURING THE PRIMARY SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 20135105 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. A FEW DAYS FOLLOWING THE SURGERY, WHILE THE PATIENT WAS STILL IN THE HOSPITAL, THEY MIS-STEPPED AND TORE MULTIPLE LIGAMENTS. PATIENT WAS REVISED A WEEK POST-IMPLANTATION DUE TO LIGAMENT AND SOFT TISSUE DAMAGE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 19323106 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY AND PAIN. THE ARTICULATING SURFACE HEIGHT WAS INCREASED FROM 11MM TO 14MM AND CHANGED FROM AN MC INSERT TO A UC INSERT TO ADDRESS THE INSTABILITY. THE PATELLA WAS REVISED TO ADDRESS ANTERIOR KNEE PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19003456 ↗
• InjuryJan 31, 2024Naturally Worn; Naturally Worn

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 18613095 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18379003 ↗
• InjuryDec 19, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 18358227 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT COMPLAINED OF PAIN, SWELLING, LIMITED EXTENSION, SEVERE LIMP, AND CHRONIC QUADRICEP WEAKNESS. THE SURGEON SUSPECTED A QUADRICEP TENDON TEAR. APPROXIMATELY ONE YEAR, SIX MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION WHERE SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED DUE TO PATELLA BAJA BUT ALL PATELLA AND QUADRICEP TENDONS WERE FOUND INTACT. THE FEMORAL, TIBIA, AND POLY WERE REVISED WITH COMPETITOR PRODUCTS. THE PATELLA WAS NOT REVISED. THE PATIENT IS ALLEGING HER COMPONENTS WERE TOO LARGE.

  Patient problems: Ambulation or Postural Difficulties; Joint effusion; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18040572 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17684051 ↗
• InjuryAug 8, 2023Fracture; Unstable; Fracture; Unstable

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17480193 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cellulitis; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17133988 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A KNEE REPLACEMENT SURGERY. SUBSEQUENTLY, 2 YEARS POST PROCEDURE THE PATIENT IS STILL SUFFERING FROM PAIN WHILE PERFORMING DAILY ACTIVITIES. PATIENT CLAIMS HE HAS BEEN FACING PAIN SINCE DAY OF THE SURGERY AND CURRENTLY CAN FEEL THE PAIN NEAR THE BONE OVERHANG AREA. POSSIBLE FUTURE REVISION.

  Patient problems: Pain

  MAUDE report 16886056 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. AT 3 MONTHS POST OP, THE PATIENT WAS PAIN FREE WITH 120 DEGREES FLEXION. APPROXIMATELY 4 MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH KNEE PAIN. THE ORIGINAL REASON FOR REVISION WAS FOR SUSPECTED INFECTION, HOWEVER, THE SURGEON MENTIONED THE KNEE DID NOT LOOK INFECTED WHEN REMOVING THE PROSTHESIS. THE SURGEON TOOK 6 SWABS, 3 ON DISTAL FEMUR AND 3 ON PROXIMAL TIBIA. WHEN REMOVING THE TIBIA, IT WAS NOTED THAT THE MEDIAL TM PEG HAD SNAPPED PRIOR TO ATTEMPTS TO REMOVE. THE BONE INGROWTH ON THE UNDERSIDE OF TM TIBIA WAS SMALL. THE PEG THAT WAS LEFT IN PATIENT HAD BONE INGROWTH. IT WAS NOTED THAT THE MEDIAL TM PEG IS NOT PERPENDICULAR TO THE BASEPLATE IN X-RAYS. ADDITIONALLY, METAL DEBRIS SEEN IN X-RAYS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 16860500 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 7 DAYS POST IMPLANTATION, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PATIENT WAS ADMITTED FOR PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE, ELEVATED TROPONINS, AND ACUTE MYOCARDIAL INJURY. THE PATIENT WAS PLACED ON ADDITIONAL ANTICOAGULANTS AND OXYGEN AND DISCHARGED 3 DAYS LATER. APPROXIMATELY 2 WEEKS LATER, THE PATIENT WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS OF THE LEFT CALF. THE PATIENT IS TAKING ELIQUIS. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: Cardiac Enzyme Elevation; Hypoxia; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 15971271 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121771, K172524. One submission often covers many models, so check the product and lot details in each record.

• Z-1917-2016 · May 11, 2016 · Terminated
  Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
• Z-1266-2015 · Jan 28, 2015 · Terminated
  Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in eit